http://www.clinicaltrials.gov. Unique identifier: NCT00753532.

BackgroundNonalcoholic fatty liver disease (NAFLD) is one of the commonest liver disorders. Obesity, insulin resistance, lipid peroxidation and oxidative stress have been identified amongst the possible hits leading to the onset and progression of this disease. Nutritional evaluation of NAFLD patients showed a lower-than-recommended intake of vitamin E. Vitamin E is a family of 8 isoforms, 4 tocopherols and 4 tocotrienols. Alpha-tocopherol has been widely investigated in liver diseases, whereas no previous clinical trial has investigated tocotrienols for NAFLD. Aim of the study was to determine the effects of mixed tocotrienols, in normalising the hepatic echogenic response in hypercholesterolaemic patients with ultrasound-proven NAFLD.MethodsEighty-seven untreated hypercholesterolaemic adults with ultrasound-proven NAFLD were enrolled and randomised into control group (n = 44) and tocotrienols group (n = 43). The treatment, either mixed tocotrienols 200 mg twice daily or placebo, had a 1-year duration.Normalisation of hepatic echogenic response, being the trial primary aim, was used in sample size calculations. The data were assessed according to intention to treat principle as primary outcome. Per protocol analysis was also carried out as secondary outcome measurement.ResultsThirty and 34 participants concluded the study in the tocotrienols and placebo group respectively. Alpha-tocopherol levels were within the normal range for all subjects. As primary outcome, the normalisation of hepatic echogenic response was significantly higher for the tocotrienols treated group compared to the placebo group in the intention to treat analysis (P = 0.039; 95% CI = 0.896-6.488). As secondary objective, the per protocol assessment also showed significant rate of remission (P = 0.014; 95% CI = 1.117-9.456). Worsening of NAFLD grade was recorded in two patients in the placebo group, but none in the group treated with tocotrienols. No adverse events were reported for both groups.ConclusionThis is the first clinical trial that showed the hepatoprotective effects of mixed palm tocotrienols in hypercholesterolemic adults with NAFLD.Trial registrationClinicaltrials.gov, NCT00753532.

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Introduction: Behavioural and Psychological Symptoms of Dementia (BPSD) are considered as integral parts of dementia. Whilst pharmacotherapy is reserved for severe symptoms of BPSD, the associated adverse effects can be detrimental. Therefore, non-pharmacological intervention is recommended to be the frontline in the management of BPSD. This study aimed to explore the non-pharmacological approaches for the management of BPSD including the strategies and barriers of implementing them in secondary care facilities in Malaysia. Methods: A qualitative study design was employed. Data were collected through observations and semi-structured interviews of twelve caregivers and eleven people with dementia (PWD) at seven secondary care facilities. Observations were written in the field notes and interviews were audio-recorded and transcribed. All data were subjected to thematic analysis. Results: Some personalised non-pharmacological interventions such as physical exercise, music therapy, reminiscence therapy, and pet therapy were conducted in several nursing care centres. Collaborative care between care providers and family members was found to be an important facilitating factor. Hence, lack of family support led to additional workload, which were beyond the job scope of the care providers. Other barriers identified for non-pharmacological interventions were cultural and language differences between care providers and PWD, inadequate staff numbers and training, as well as time constraints. Conclusion: Although non-pharmacological approaches have been conducted to some extent in Malaysia, continuous education and training for the healthcare providers as well as the family members of PWD are needed to overcome the challenges with regards to their successful implementation.